[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186]
 
[Page 566]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
 
                      Subpart A--General Provisions
 
Sec.
186.1  Substances added indirectly to human food affirmed as generally 
          recognized as safe (GRAS).
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
186.1093  Sulfamic acid.
186.1256  Clay (kaolin).
186.1275  Dextrans.
186.1300  Ferric oxide.
186.1316  Formic acid.
186.1374  Iron oxides.
186.1551  Hydrogenated fish oil.
186.1555  Japan wax.
186.1557  Tall oil.
186.1673  Pulp.
186.1750  Sodium chlorite.
186.1756  Sodium formate.
186.1770  Sodium oleate.
186.1771  Sodium palmitate.
186.1797  Sodium sulfate.
186.1839  Sorbose.
 
    Authority: 21 U.S.C. 321, 342, 348, 371.
 
    Source: 42 FR 14658, Mar. 15, 1977, unless otherwise noted.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1]
 
[Page 566-568]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 186.1  Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).
 
 
    (a) The indirect human food ingredients listed in this part have 
been reviewed by the Food and Drug Administration and determined to be 
generally recognized as safe (GRAS) for the purposes and under the 
conditions prescribed, providing they comply with the purity 
specifications listed in this part or, in the absence of purity 
specifications, are of a purity suitable for their intended use in 
accordance with Sec. 170.30(h)(1) of this chapter. Certain ingredients 
in this part may also be used in food-contact surfaces in accordance 
with parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter. 
Ingredients affirmed as GRAS for direct use in part
 
[[Page 567]]
 
184 of this chapter are also GRAS as indirect human food ingredients in 
accordance with Sec. 184.1(a) of this chapter.
    (b) The regulations in this part do not authorize direct addition of 
any food ingredient to a food. They authorize only the use of these 
ingredients as indirect ingredients of food, through migration from 
their immediate wrapper, container, or other food-contact surface. Any 
ingredient affirmed as GRAS in this part shall be used in accordance 
with current good manufacturing practice. For the purpose of this part, 
current good manufacturing practice includes the requirements that an 
indirect human food ingredient be of a purity suitable for its intended 
use, and that it be used at a level no higher than reasonably required 
to achieve its intended technical effect in the food-contact article.
    (1) If the ingredient is affirmed as GRAS with no limitations on its 
conditions of use other than current good manufacturing practice, it 
shall be regarded as GRAS if its conditions of use are consistent with 
the requirements of paragraphs (b), (c), and (d) of this section. When 
the Food and Drug Administration (FDA) determines that it is 
appropriate, the agency will describe one or more current good 
manufacturing practice conditions of use in the regulation that affirms 
the GRAS status of the indirect ingredient. For example, when the safety 
of an ingredient has been evaluated on the basis of limited conditions 
of use, the agency will describe in the regulation that affirms the GRAS 
status of the indirect ingredient, one or more of these limited 
conditions of use, which may include the category of food-contact 
surface(s), technical effect(s) or functional use(s) of the indirect 
ingredient, and the level(s) of use. If the ingredient is used under 
conditions that are significantly different from those described in the 
regulation, such use of a substance may not be GRAS. In such a case, a 
manufacturer may not rely on the regulation as authorizing that use but 
shall independently establish that the use is GRAS or shall use the 
ingredient in accordance with a food additive regulation. Persons 
seeking FDA approval of an independent determination that a use of an 
ingredient is GRAS may submit a GRAS petition in accordance with 
Sec. 170.35 of this chapter.
    (2) If the ingredient is affirmed as GRAS with specific 
limitation(s), it shall be used in food-contact surfaces only within 
such limitation(s), including the category of food-contact surface(s), 
the functional use(s) of the ingredient, and the level(s) of use. Any 
use of such an ingredient not in full compliance with each such 
established limitation shall require a food additive regulation.
    (3) If the ingredient is affirmed as GRAS for a specific use, prior 
to general evaluation of use of the ingredient, other uses may also be 
GRAS.
    (c) The listing of a food ingredient in this part does not authorize 
the use of such substance for the purpose of adding the ingredient to 
the food through extraction from the food-contact surface.
    (d) The listing of a food ingredient in this part does not authorize 
the use of such substance in a manner that may lead to deception to the 
consumer or to any other violation of the Federal Food, Drug, and 
Cosmetic Act (the Act).
    (e) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of an ingredient under conditions different from those 
proposed to be affirmed as GRAS, he will concurrently propose a separate 
regulation covering such use of the ingredient under part 181 of this 
chapter. If the Commissioner is unaware of any such applicable prior 
sanction, the proposed regulation will so state and will require any 
person who intends to assert or rely on such sanction to submit proof of 
its existence. Any regulation promulgated pursuant to this section 
constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a
 
[[Page 568]]
 
regulation is determined to be appropriate as a result of submission of 
proof of such an applicable prior sanction in response to the proposal.
 
[42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19, 
1983]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1]
 
[Page 566-568]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 186.1  Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).
 
 
    (a) The indirect human food ingredients listed in this part have 
been reviewed by the Food and Drug Administration and determined to be 
generally recognized as safe (GRAS) for the purposes and under the 
conditions prescribed, providing they comply with the purity 
specifications listed in this part or, in the absence of purity 
specifications, are of a purity suitable for their intended use in 
accordance with Sec. 170.30(h)(1) of this chapter. Certain ingredients 
in this part may also be used in food-contact surfaces in accordance 
with parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter. 
Ingredients affirmed as GRAS for direct use in part
 
[[Page 567]]
 
184 of this chapter are also GRAS as indirect human food ingredients in 
accordance with Sec. 184.1(a) of this chapter.
    (b) The regulations in this part do not authorize direct addition of 
any food ingredient to a food. They authorize only the use of these 
ingredients as indirect ingredients of food, through migration from 
their immediate wrapper, container, or other food-contact surface. Any 
ingredient affirmed as GRAS in this part shall be used in accordance 
with current good manufacturing practice. For the purpose of this part, 
current good manufacturing practice includes the requirements that an 
indirect human food ingredient be of a purity suitable for its intended 
use, and that it be used at a level no higher than reasonably required 
to achieve its intended technical effect in the food-contact article.
    (1) If the ingredient is affirmed as GRAS with no limitations on its 
conditions of use other than current good manufacturing practice, it 
shall be regarded as GRAS if its conditions of use are consistent with 
the requirements of paragraphs (b), (c), and (d) of this section. When 
the Food and Drug Administration (FDA) determines that it is 
appropriate, the agency will describe one or more current good 
manufacturing practice conditions of use in the regulation that affirms 
the GRAS status of the indirect ingredient. For example, when the safety 
of an ingredient has been evaluated on the basis of limited conditions 
of use, the agency will describe in the regulation that affirms the GRAS 
status of the indirect ingredient, one or more of these limited 
conditions of use, which may include the category of food-contact 
surface(s), technical effect(s) or functional use(s) of the indirect 
ingredient, and the level(s) of use. If the ingredient is used under 
conditions that are significantly different from those described in the 
regulation, such use of a substance may not be GRAS. In such a case, a 
manufacturer may not rely on the regulation as authorizing that use but 
shall independently establish that the use is GRAS or shall use the 
ingredient in accordance with a food additive regulation. Persons 
seeking FDA approval of an independent determination that a use of an 
ingredient is GRAS may submit a GRAS petition in accordance with 
Sec. 170.35 of this chapter.
    (2) If the ingredient is affirmed as GRAS with specific 
limitation(s), it shall be used in food-contact surfaces only within 
such limitation(s), including the category of food-contact surface(s), 
the functional use(s) of the ingredient, and the level(s) of use. Any 
use of such an ingredient not in full compliance with each such 
established limitation shall require a food additive regulation.
    (3) If the ingredient is affirmed as GRAS for a specific use, prior 
to general evaluation of use of the ingredient, other uses may also be 
GRAS.
    (c) The listing of a food ingredient in this part does not authorize 
the use of such substance for the purpose of adding the ingredient to 
the food through extraction from the food-contact surface.
    (d) The listing of a food ingredient in this part does not authorize 
the use of such substance in a manner that may lead to deception to the 
consumer or to any other violation of the Federal Food, Drug, and 
Cosmetic Act (the Act).
    (e) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of an ingredient under conditions different from those 
proposed to be affirmed as GRAS, he will concurrently propose a separate 
regulation covering such use of the ingredient under part 181 of this 
chapter. If the Commissioner is unaware of any such applicable prior 
sanction, the proposed regulation will so state and will require any 
person who intends to assert or rely on such sanction to submit proof of 
its existence. Any regulation promulgated pursuant to this section 
constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a
 
[[Page 568]]
 
regulation is determined to be appropriate as a result of submission of 
proof of such an applicable prior sanction in response to the proposal.
 
[42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19, 
1983]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1093]
 
[Page 568]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1093  Sulfamic acid.
 
 
    (a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329-
14-6) is a white crystalline solid manufactured from urea, sulfur 
trioxide, and sulfuric acid. It is soluble and highly ionized in water.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect food ingredient with no limitations other than current good 
manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe (GRAS) as an indirect human food ingredient is based 
upon the current good manufacturing practice of using this ingredient in 
the manufacture of paper and paperboard that contact food.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[47 FR 29954, July 9, 1982]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1256]
 
[Page 568]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1256  Clay (kaolin).
 
    (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. 
No. 1332-58-7) consists of hydrated aluminum silicate. The commercial 
products of clay (kaolin) contain varying quantities of alkalies and 
alkaline earths. Clay (kaolin) is a white to yellowish or grayish fine 
powder. There are at least three different minerals, kaolinite, dickite, 
and nacrite, classified as kaolin. Kaolinite or china clay is whiter, 
less contaminated with extraneous minerals, and less plastic in water.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used in the manufacture of paper and 
paperboard that contact food.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.
 
[47 FR 43367, Oct. 1, 1982]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1275]
 
[Page 568]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1275  Dextrans.
 
    (a) Dextrans (CAS Reg. No. 9004-54-0) are high molecular weight 
polysaccharides produced by bacterial fermentation of sucrose. 
Commercially available dextrans are synthesized from sucrose by 
Leuconostoc mesenteroides strain NRRL B-512(F). Partial depolymerization 
and purification of the fermented mixture shall produce a product that 
is free of viable microorganisms.
    (b) The ingredient is used or intended for use as a constituent of 
food-contact surfaces.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1300]
 
[Page 568-569]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1300  Ferric oxide.
 
    (a) Ferric oxide (iron (III) oxide, Fe2O3, CAS 
Reg. No. 1309-37-1) occurs naturally as the mineral hematite. It may be 
prepared synthetically by heating brown iron hydroxide oxide. The 
product is red-brown to black trigonal crystals.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as a constituent of paper and paperboard 
used for food packaging.
 
[[Page 569]]
 
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1316]
 
[Page 569]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1316  Formic acid.
 
    (a) Formic acid (CH2O2, CAS Reg. No. 64-18-6) 
is also referred to as methanoic acid or hydrogen carboxylic acid. It 
occurs naturally in some insects and is contained in the free acid state 
in a number of plants. Formic acid is prepared by the reaction of sodium 
formate with sulfuric acid and is isolated by distillation.
    (b) Formic acid is used as a constituent of paper and paperboard 
used for food packaging.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (d) Prior sanctions for formic acid different from the uses 
established in this section do not exist or have been waived.
 
[45 FR 22915, Apr. 4, 1980]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1374]
 
[Page 569]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1374  Iron oxides.
 
    (a) Iron oxides (oxides of iron, CAS Reg. No. 97705-33-85) are 
undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black 
cubic crystals) and iron (III) oxide (CAS Reg. No. 1309-37-1, red-brown 
to black trigonal crystals).
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as a constituent of paper and paperboard 
used for food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1551]
 
[Page 569]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1551  Hydrogenated fish oil.
 
    (a) Hydrogenated fish oil (CAS Reg. No. 91078-95-4) is a class of 
oils produced by partial hydrogenation of oils expressed from fish, 
primarily menhaden, and secondarily herring or tuna. Hydrogenation of 
fish oils uses catalysts composed of either elemental nickel, elemental 
copper, or a mixture of these elements. The crude hydrogenated fish oil 
is further processed by alkali refining, bleaching, and deodorization by 
steam stripping.
    (b) Hydrogenation of fish oils results in a final product with a 
melting point greater than 32  deg.C as determined by Section Cc 1-25, 
Official and Tentative Methods of the American Oil Chemists' Society 
method (reapproved 1973) or equivalent. The product has an approximate 
fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 
55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 
to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic 
or higher polyenoic fatty acids. The approximate percentages of total 
fatty acids by carbon chain length are 15 to 30 percent each of 
C16, C18, C20, C22, less 
than 10 percent C14 or lower carbon chain length, and less 
than 1 percent C24 or higher carbon chain length fatty acids.
    (c) The ingredient is used as a constituent of cotton and cotton 
fabrics used for dry food packaging.
    (d) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (e) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.
 
[44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14. 1984; 58 
FR 17099, Apr. 1, 1993]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1555]
 
[Page 569-570]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1555  Japan wax.
 
    (a) Japan wax (CAS Reg. No. 8001-39-6), also known as Japan tallow 
or sumac wax, is a pale yellow vegetable tallow, containing glycerides 
of the C19-C23 dibasic acids and a high content
 
[[Page 570]]
 
of tripalmitin. It is prepared from the mesocarp by hot pressing of 
immature fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan, 
and Indo-China), R. vernicifera (Japan), and R. trichocarpa (China, 
Indo-China, India, and Japan). Japan wax is soluble in hot alcohol, 
benzene, and naphtha, and insoluble in water and in cold alcohol.
    (b) In accordance with paragraph (b)(1) of this section, the 
ingredient is used as an indirect human food ingredient with no 
limitation other than current good manufacturing practice. The 
affirmation of this ingredient as generally recognized as safe (GRAS) as 
an indirect human food ingredient is based on the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as a constituent of cotton and cotton 
fabrics used for dry food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[60 FR 62208, Dec. 5, 1995]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1557]
 
[Page 570]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1557  Tall oil.
 
    (a) Tall oil (CAS Reg. No. 8002-26-4) is essentially the sap of the 
pine tree. It is obtained commercially from the waste liquors of 
pinewood pulp mills and consists mainly of tall oil resin acids and tall 
oil fatty acids.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based on the following current good manufacturing practice conditions 
of use:
    (1) The ingredient is used as a constituent of cotton and cotton 
fabrics used for dry food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section, or from those listed in part 181 of this 
chapter, do not exist or have been waived.
 
[51 FR 16830, May 7, 1986]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1673]
 
[Page 570]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1673  Pulp.
 
    (a) Pulp is the soft, spongy pith inside the stem of a plant such as 
wood, straw, sugarcane, or other natural plant sources.
    (b) The ingredient is used or intended for use as a constituent of 
food packaging containers.
    (c) The ingredient is used in paper and paperboard made by 
conventional paper-making processes at levels not to exceed good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1750]
 
[Page 570]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1750  Sodium chlorite.
 
    (a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758-19-2) 
exists as slightly hygroscopic white crystals or flakes. It is 
manufactured by passing chlorine dioxide into a solution of sodium 
hydroxide and hydrogen peroxide.
    (b) the ingredient is used at levels from 125 to 250 parts per 
million as a slimicide in the manufacture of paper and paperboard that 
contact food.
 
[45 FR 16470, Mar. 14, 1980]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1756]
 
[Page 570]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1756  Sodium formate.
 
    (a) Sodium formate (CHNaO2, CAS Reg. No. 141-53-7) is the 
sodium salt of formic acid. It is produced by the reaction of carbon 
monoxide with sodium hydroxide.
    (b) The ingredient is used as a constituent of paper and paperboard 
used for food packaging.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (d) Prior sanctions for sodium formate different from the uses 
established in this section do not exist or have been waived.
 
[45 FR 22915, Apr. 4, 1980]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1770]
 
[Page 570-571]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1770  Sodium oleate.
 
    (a) Sodium oleate (C18H33O2Na, CAS 
Reg. No. 143-19-1) is the sodium salt of oleic acid (cis-9-octadecenoic 
acid). It exists as a white to yellowish powder
 
[[Page 571]]
 
with a slight tallow-like odor. Commercially, sodium oleate is made by 
mixing and heating flaked sodium hydroxide and oleic acid.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a 
constituent of paper and paperboard for food packaging and as a 
component of lubricants with incidental food contact in accordance with 
Sec. 178.3570 of this chapter, with no limitation other than current 
good manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[51 FR 39372, Oct. 28, 1986]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1771]
 
[Page 571]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1771  Sodium palmitate.
 
    (a) Sodium palmitate (C16H31O2Na, 
CAS Reg. No. 408-35-5) is the sodium salt of palmitic acid (hexadecanoic 
acid). It exists as a white to yellow powder. Commercially, sodium 
palmitate is made by mixing and heating flaked sodium hydroxide and 
palmitic acid.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a 
constituent of paper and paperboard for food packaging with no 
limitation other than current good manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[51 FR 39372, Oct. 28, 1986]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1797]
 
[Page 571]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1797  Sodium sulfate.
 
    (a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757-
82-6), also known as Glauber's salt, occurs naturally and exists as 
colorless crystals or as a fine, white crystalline powder. It is 
prepared by the neutralization of sulfuric acid with sodium hydroxide.
    (b) The ingredient is used as a constituent of paper and paperboard 
used for food packaging, and cotton and cotton fabric used for dry food 
packaging.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[45 FR 6086, Jan. 25, 1980]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR186.1839]
 
[Page 571]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
 
       Subpart B--Listing of Specific Substances Affirmed as GRAS
 
Sec. 186.1839  Sorbose.
 
    (a) Sorbose (L-sorbose, sorbinose) 
(C6H12O6, CAS Reg. No. 87-79-6) is an 
orthorhombic, bisphenoidal crystalline ketohexose. It was originally 
identifed in the juice of mature berries from the mountain ash (Sorbus 
aucuparia) where it occurs as the result of microbial oxidation of 
sorbitol. It also occurs naturally in other plants. Sorbose can be 
synthesized by the catalytic hydrogenation of glucose to D-sorbitol. The 
resulting sorbitol can be oxidized by Acetobacter xylinum or by 
Acetobacter suboxydans.
    (b) The ingredient is used or intended for indirect food use as a 
constituent of cotton, cotton fabrics, paper, and paperboard in contact 
with dry food.
    (c) The ingredient migrates to food at levels not to exceed good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
 
[43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19, 1983]